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News

Accord’s Immgolis™ / Immgolis Intri™ (golimumab-sldi) Approved as First Simponi® / Simponi Aria® (golimumab) Interchangeable Biosimilars

by Robert S. Schwartz, Ph.D.
May 18, 2026

On May 15, 2026, the FDA approved the first biosimilars of Janssen’s Simponi® / Simponi Aria® (golimumab), Accord and Bio-Thera’s Immgolis™ / Immgolis Intri™ (golimumab-sldi).  Both biosimilars were approved with skinny labels.  Immgolis™ is approved for adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate and adult patients with moderate to severely active ulcerative colitis.  Immgolis Intri™ is approved for adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.  Immgolis™ and Immgolis Intri™ were designated as interchangeable for rheumatoid arthritis and ulcerative colitis.

In March 2026, Janssen filed BPCIA litigation No. 1:26-cv-00222 (D. Del.) against Accord and Bio-Thera alleging infringement of seven of Janssen’s patents (previously reported Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar).  Later in March, Accord and Bio-Thera filed IPR2026-00256, IPR2026-00257, IPR2026-00258, and IPR2026-00259 alleging claims of four of the asserted patents (U.S. Patent Nos. 11,014,982; 11,041,020; 12,122,824; and 12,291,566) are invalid as anticipated and obvious (previously reported Accord and Bio-Thera File Four IPRs Challenging Janssen Simponi® Patents).  The IPRs are awaiting institution decisions and the litigation is pending.  On May 6, 2026, Janssen filed a motion for a preliminary injunction that is awaiting a decision.

There is one other publicly announced pending aBLA for Simponi® / Simponi Aria® biosimilars, Alvotech / Teva’s AVT05, which was accepted by the FDA in January 2025 and received a Complete Response Letter in November 2025 (previously reported FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05).  Alvotech recently announced plans to resubmit the aBLA in June.

Johnson & Johnson reported U.S. sales of $1.2B for Simponi® / Simponi Aria® in 2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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